Advocate General issues opinion in Royalty Pharma and Sandoz v Searle SPC cases

Background

Advocate General (AG) Gerard Hogan has issued his opinion in connection with two requests for a preliminary ruling regarding the interpretation of the requirement in Article 3(a) of the Supplementary Protection Certificate (SPC) Regulation that the product must be “protected by a basic patent in force”. The referrals, C-650/17 (Royalty Pharma) and C-114/18 (Sandoz v Searle), were joined by the CJEU and the full text of the AG’s opinion can be found here.

Various previous decisions of the CJEU have addressed the question of how Article 3(a) of the SPC regulation should be interpreted. The most recent of these is C-121/17 (Teva v Gilead), in which the CJEU held that a product composed of several active ingredients is “protected by a basic patent in force” where:

“even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

(i)    the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

(ii)    each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”

Cases C-650/17 and C-114/18 deal with the issue of how Article 3(a) should be interpreted in cases where a single active ingredient is defined in the patent either functionally, or by reference to a Markush structure. In particular, in case C-650/17, the authorised product is sitagliptin, but the basic patent defines the product functionally as a DP-IV inhibitor. In case C-114/18, the authorised product is darunavir, which is encompassed by the Markush structure in the claims of the basic patent.

The AG’s opinion

The AG’s opinion is that Article 3(a) of the SPC Regulation does not preclude the grant of an SPC for an active ingredient which is covered by a functional definition or a Markush formula, provided that the two part test which the CJEU set out in C-121/17 (see above) is satisfied. This test is equally applicable both to products consisting of a single active ingredient and to products composed of several active ingredients and must be applied from the point of view of the skilled person and on the basis of the prior art at the filing date or priority date of the basic patent.

Step (i) of the Teva v Gilead test is to determine whether the product “necessarily” falls under the invention covered by the basic patent. According to the AG, step (i) is satisfied “if the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent”.  Conversely, if “the claims in a patent in relation to a product are not required for the solution of the technical problem disclosed by a patent”, then the test is not satisfied and an SPC may not be granted. Contrary to the suggestion of the UK Court in its referral in the Teva v Gilead case, the question of whether the product embodies the “core inventive advance” of the patent is of no relevance.

Step (ii) of the Teva v Gilead test is to determine whether the product is “specifically identifiable” in the light of all the information disclosed by the patent. The AG’s opinion is that the product is “specifically identifiable” if the skilled person would have been able “in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question”. Conversely, a product is not “specifically identifiable” if, “in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or priority date of the patent in question”.

The AG’s opinion is not binding on the CJEU, and it remains to be seen whether the CJEU will follow the same approach. SPC holders will take comfort in the AG’s confirmation that functional definitions and Markush claims do not preclude SPC protection, but questions remain regarding the practical circumstances in which the Teva v Gilead test can be satisfied in such cases. We therefore await with interest both the CJEU’s decision and its subsequent interpretation by the national courts in the UK and Germany.

For further details about SPCs, visit our webpage here, or find out more about our pharmaceuticals team’s medical regulations experience here.